BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHA STIM 100 MICROCURRENT AND CRANIAL ELECTROTHERAPY

    MDR report key: 2585144 · Received May 17, 2012

    Report

    Report Number
    MW5025466
    Event Type
    Malfunction
    Date Received
    May 17, 2012
    Report Date
    May 17, 2012
    Manufacturer
    ELECTROMEDICAL PRODUCTS INT'L
    Product Code
    JXK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A TREATMENT, PT WAS BURNED ON BOTH EARS BY THE DEVICE THAT WAS USED. PT WAS USING THE DEVICE AS PRESCRIBED AND INSTRUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA STIM 100 MICROCURRENT AND CRANIAL ELECTROTHERAPY ALPHA STIM JXK ELECTROMEDICAL PRODUCTS INT'L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other